Pharmaceutical Senior Manager – Engineering

Umanist Staffing•Chantilly, VA

6d•Onsite

About The Position

We are seeking an experienced Senior Manager, Engineering to lead engineering and facility operations at a pharmaceutical Oral Solid Dosage (OSD) manufacturing facility in Chantilly, VA. The ideal candidate will have extensive hands-on experience in US-based pharmaceutical OSD manufacturing, with strong expertise in OSD production equipment, facility engineering, HVAC, cleanrooms, critical utilities, equipment reliability, maintenance, capital projects, and FDA cGMP compliance. This role will provide technical and operational leadership across engineering, facilities, utilities, equipment reliability, and continuous improvement.

Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or a related field.
12+ years of engineering experience within pharmaceutical manufacturing.
Significant direct experience in Oral Solid Dosage (OSD) manufacturing.
Strong hands-on knowledge of OSD equipment including granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging equipment.
Strong knowledge of facility engineering, HVAC, cleanrooms, clean utilities, compressed air, chilled water, boilers, vacuum systems, and environmental controls.
Experience with preventive maintenance, equipment reliability, and calibration.
Proven experience leading engineering and facilities teams.
Strong understanding of FDA cGMP, validation, CAPA, change control, and regulatory compliance.
Demonstrated experience working in US-based pharmaceutical manufacturing facilities and operations.
Direct familiarity with US regulatory standards, OSHA requirements, local permitting, building codes, and FDA cGMP compliance is mandatory.
Strong leadership, troubleshooting, project management, and communication skills.
12+ years of pharmaceutical engineering experience.
Direct OSD manufacturing experience.
Hands-on experience with OSD manufacturing equipment.
Hands-on experience in US-based pharmaceutical facilities.
Strong HVAC, cleanroom, utilities, and facility engineering knowledge.
Engineering and facilities leadership experience.
Strong FDA cGMP and US regulatory knowledge.
Experience with equipment PM and calibration.
US Citizen or Green Card Holder.
Candidates without direct US pharmaceutical OSD manufacturing experience will not be considered.

Responsibilities

Lead engineering and facilities teams supporting OSD manufacturing, packaging, utilities, and facility systems.
Provide technical leadership for equipment troubleshooting, optimization, reliability, and process improvements.
Oversee installation, qualification, preventive maintenance, calibration, and maintenance of OSD manufacturing equipment.
Support equipment including granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines.
Lead root-cause investigations and implement CAPA for equipment and process-related issues.
Manage HVAC systems, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and other critical utilities.
Ensure facility environmental controls meet cGMP requirements for temperature, humidity, pressure differentials, and air quality.
Develop and manage preventive maintenance and equipment reliability programs.
Support facility expansions, renovations, infrastructure upgrades, and capital projects.
Ensure engineering and facility operations comply with FDA cGMP, OSHA, environmental regulations, US building codes, and applicable regulatory requirements.
Support audits, inspections, validation activities, change controls, and engineering documentation.
Conduct and support risk assessments including FMEA and HAZOP.
Drive continuous improvement initiatives using Lean, Six Sigma, and reliability engineering methodologies.
Identify opportunities for automation, modernization, equipment optimization, and energy efficiency.
Mentor and develop engineering and facilities personnel and build a high-performing engineering organization.